India centralizes drug product licensing from October 1

Drug manufacturers with valid product licences issued by state authorities can use them till expiry

India will centralize licensing for pharmaceutical products from October 1,2009, as part of its ongoing programme to streamline the regulatory process with respect to pharmaceutical manufacturing and licensing.

WHO-GMP Certificate of Pharmaceutical Product (CoPP) will be issued to drug manufacturers by the Drug Controller General of India – country’s central drug authority — through his Central Drug Standards Control Oraganisation (CDSCO) offices from October 1.

Certificate of Pharmaceutical Product (CoPP) and GMP certicates have been issued in India, currrently, by the state drug authorities.The decision to take back the authority from the states was made during the 40th drug consultative committee meeting in June, after repeated concerns by WHO over quality of pharmaceutical products moving in international commerce.

Apart from CDSCO, 12 other officers including all heads of zonal and sub-zonal offices under CDSCO will also be resposible for issuing Certificate of Pharmaceutical Product (CoPP),according to the guidelines issued by Drug Controller General India’s (DCGI) office.

Manufacturers can apply for grant of WHO GMP Certificate of Pharmaceutical Product to respective zonal/sub zonal officers as per the requirement prescribed below.

WHO GMP Certificate of Pharmaceutical Product will be issued by zonal/sub zonal officers on behalf of Drugs Controller General (India) after inspection and satisfactory clearance by CDSCO officers mandated by WHO – GMP guidelines.

The Certificate of Pharmaceutical Product will be issued only in the format recommended by WHO, for which a model of CoPP application is provide in DCGI website.

No fee will be charged for application for the Certificate of Pharmaceutical Product till final decision is taken and published in this matter.

Meanwhile, manufacturers who are already holding COPP shall continue to use it till its expiry.

Manufacturers should submit application to DDC(I)/ADC(I) of respective CDSCO zonal/sub zonal offices with copy of covering letter & product summary sheet to DCG(I) (WHO-cell).

The application for Certificate of Pharmaceutical Product should accompany with list of products applied for grant of COPP, along with the product permission copy (manufacturing licence issued by the state licensing authorities & notarized product summary sheet, site master file as per WHO-GMP requirement.

Manufacturers seeking Certificate of Pharmaceutical Product should also provide list of documents like master validation plan, quality manuals, specifications, master formula records maintained by firm and list of SOP’s to indicate the documentation system of firm, manufacturing layout, HVAC schematics and details of areas (Where in clearly specify the filtration level & classification of core areas & rooms as required in section 3.3 of SMF and Water system – Schematic diagrams along with the components, list of personnel (with designation, qualification & experience), list of equipments, instruments, utilities along with make and model & capacity and list of primary & secondary Impurity and reference standards/cultures available with the firm relevant to the applied products for grant of COPP, the CDSCO guidelines said.

CDSCO has notified earlier this month to all state drug authorities that DCGI will become the authority to issue the WHO-mandated Certificate of Pharmaceutical Products (CoPP) and WHO Certification Scheme for Good Manufacturing Practices (GMP) for medicinal products, from October 1, 2009.

The WHO certification scheme is an an administrative tool developed in response to the requests of WHO member states. It is a voluntary/non binding agreement to exchange information on the quality safety and efficacy imported drugs.

CoPPs are intended to give assurance to countries that are importing pharmaceutical products but have no national capacity to assess the safety, efficacy and quality of the drugs they import.

CoPPs enable importing countries to get all the information they need to know about the product they import.

CoPPs while providing information on the product, on GMP status of the manufacturing plant assures that the product information accompanying the certificate is the same as the one approved by the certifying country.

CoPPs also provides information about the certifying authority. It makes companies to apply GMP requirements similar to those recommended by WHO.

Centralisation of drug licensing and manufacturing can be viewed as latest in a series of effective initiatives taken by the CDSCO as part of its efforts to streamline and reform the entire drug regulatory mechanism.

DCGIs office has recently set clear timeline for clearing and processing applications and issuance of certifications. Besides de-cluttering the licensing, registration processes CDSCO has also brought specific set of guideline for medical devices, for compulsory registration clinical trials etc.

CDSCO’s move to stremline export licesing and manufacturing also achieve significance at a time made-in-India generic drugs bear the brunt of quality in some destinations especially in the African continent.